Z-0941-2022Class II

Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

Name: Z-0941-2022 Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-03-09
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-03-09 / Terminated / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box on 2022-03-09. FDA classified it as Class II and gives the reason as "The mask cuff may disconnect from the device's breathing tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0941-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-09
Posted: 2022-04-14
Terminated: 2026-05-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Product code: CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall: The mask cuff may disconnect from the device's breathing tube.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline Industries, Inc. notified all affected consignees via first class mail on March 8, 2022. Medline Industries, LP. has provided each consignee with a letter and a Destruction form to record their response to the recall notification. Each Response received will be recorded and Medline Industries, LP. will send subsequent letters to consignees that have not provided a response to our recall notification in the allotted time. Each consignee was provided with a destruction form to complete and return. The consignees are responsible to destroy their product per their local and state regulations. No product will be returned to be stored.
Quantity in commerce: 8990 cases
Distribution: US Nationwide distribution.
Product codes and lots: Medline Item Number and Lot(s): 1) DYND290010; Lot 63521050001 (UDI: 10193489036688) 2) DYND290015; Lot 63521050001 (UDI: 10193489036695) 3) DYND290020; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036701) 4) DYND290025; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036718) 5) DYND290030; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036725) 6) DYND290040; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036732) 7) DYND290050; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036749)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0941-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0941-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)